DEPUY SYNTHES PRODUCTS LLC KINCISE CUP-ADAPTER-PINNACLE STRAIGHT; MOTOR, SURGICAL INSTRUMENT, AC-POWERED
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Catalog Number 1011-01-101 |
Device Problems
Crack (1135); Material Twisted/Bent (2981)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 04/30/2019 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Device manufacture date: the device manufacture date is unavailable.As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Event Description
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It was reported that during an unspecified surgical procedure, it was discovered that the kincise cup-adapter pinnacle device was cracked and bent.It was not reported if there were any delays in the surgical procedure or if a spare device was available for use.There was patient involvement reported.There were no reports of injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.
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Manufacturer Narrative
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Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Device manufacture date: the device manufacture date was unknown in the initial report.The device manufacture date has been updated as 6/18/2018.The actual device was returned for evaluation.Quality engineering evaluated the device.A visual and functional assessment was performed which determined that the device visibly had a broken t-handle and the pinnacle adapter was non-functional.During service/repair, it was determined that the unit was most likely used to slide load with the impactor which was not what the unit was designed for (went from a thread connection with the adapter body to combining the adapter body and adapter stem into a single part).Therefore, the reported condition was confirmed.The assignable root cause was determined to be due to user misuse.If additional information should become available, a supplemental medwatch report will be submitted accordingly.
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Search Alerts/Recalls
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